Orange Book product · Brand (NDA)
CRENESSITY
CRINECERFONT
At a glance
Dec 13, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 13, 2024
1 yr 6 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Dec 13, 2029
in 3 yr 6 mo
Exclusivity ends · ODE-503
Orphan-drug exclusivity (7 years)
Dec 13, 2031
in 5 yr 7 mo
Patent 10905690 expires
Listed method-of-use patent (U-4049) expiration.
Jan 21, 2035
in 8 yr 9 mo
Patent 11311544 expires
Listed method-of-use patent (U-4049) expiration.
Jan 21, 2035
in 8 yr 9 mo
Patent 11730739 expires
Listed method-of-use patent (U-4049) expiration.
Jan 21, 2035
in 8 yr 9 mo
Patent 12128033 expires
Listed drug substance patent expiration.
Jun 09, 2041
in 15 yr 2 mo
Patent 12582634 expires
Listed drug substance patent expiration.
Jan 12, 2043
in 16 yr 10 mo
Pharmaceutical detail
Active ingredient
CRINECERFONT
Strength
50MG/ML
Dosage form
SOLUTION
Route
ORAL
TE code
Not listed
Application
NDA 218820
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (2)
- NCENew chemical entity exclusivity (5 years)
Dec 13, 2029
in 3 yr 6 mo
- ODE-503Orphan-drug exclusivity (7 years)
Dec 13, 2031
in 5 yr 7 mo
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10905690 | Jan 21, 2035 | in 8 yr 9 mo | U-4049 |
| 11311544 | Jan 21, 2035 | in 8 yr 9 mo | U-4049 |
| 11730739 | Jan 21, 2035 | in 8 yr 9 mo | U-4049 |
| 12128033 | Jun 09, 2041 | in 15 yr 2 mo | SubstanceU-4049 |
| 12582634 | Jan 12, 2043 | in 16 yr 10 mo | Substance |
